Dataset Information

Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial.

ABSTRACT:

Background and purpose

Total shoulder arthroplasty (TSA) and shoulder exercises are both effective treatments for reducing pain and improving function in glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared with non-surgical treatment in a randomized controlled trial. We will examine whether TSA followed bystandard postsurgical rehabilitation is superior to a 12-week exercise program in patients with primary glenohumeral OA who are eligible for unilateral TSA.

Patients and methods

In this Nordic multicenter randomized controlled clinical trial, patients with glenohumeral osteoarthritis eligible for TSA will be allocated to either TSA followed by usual care or exercise only. The exercise intervention comprises 12 weeks of exercise with one weekly physiotherapist-supervised session. Based on the sample size calculation, the trial needs to include 102 patients. Duration and outcome: Recruitment was initiated in April 2021 and is expected to be completed by the end of March 2024. Primary outcome is patient-reported quality of life, measured as total WOOS score 12 months after initiation of treatment. The key secondary outcomes include patient-reported pain intensity at rest and during activity; Disabilities of the Arm, Shoulder, and Hand score (DASH); the use of analgesics during the previous week; and adverse events.

Trial registration

The trial is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-29-21) and by the Danish Data Protection Agency (Journal No 1-16-02-199-21). ClinicalTrials.gov Identifier: NCT04845074.

SUBMITTER: Beck Larsen J

PROVIDER: S-EPMC8826696 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial.

Beck Larsen Josefine J Thillemann Theis Muncholm TM Launonen Antti P AP Østergaard Helle Kvistgaard HK Falstie-Jensen Thomas T Reito Aleksi A Lund Jensen Steen S Mechlenburg Inger I

Acta orthopaedica 20220208

<h4>Background and purpose</h4>Total shoulder arthroplasty (TSA) and shoulder exercises are both effective treatments for reducing pain and improving function in glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared with non-surgical treatment in a randomized controlled trial. We will examine whether TSA followed bystandard postsurgical rehabilitation is superior to a 12-week exercise program in patients with primary glenohumeral OA who are eligible for unilateral ...[more]

PMID: 35138410

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Project description:BackgroundGlenohumeral instability is a highly prevalent pathology; however, there are problems in defining it. Traditionally, structural problems such as labral injury or bone loss in the glenoid cavity and/or humeral side were considered the main causes; but recently, it has been seen that motor control plays a very relevant role. This means that currently, there is a disparity of action protocols, and the treatment of this pathology is a great challenge.AimThe primary aim of this study is to evaluate the effectiveness of a supervised multicomponent therapeutic exercise program in reducing multivariable fatigue in patients with instability of the glenohumeral joint.MethodsA single-blind randomized controlled trial will be carried out, in which 108 adult patients who have suffered at least one episode of glenohumeral instability in the last year will be recruited by the Department of Traumatology and Rehabilitation of Axarquia Hospital (Málaga). Patients will be randomized to the intervention group, which will carry out a multicomponent therapeutic exercise program supervised by physiotherapists (MoveUS Program); or to the control group, which will receive the usual care. All subjects will be evaluated at baseline, mid-treatment, after the intervention, and three months later at the follow-up. In these evaluations, range of movement, maximum peak of isometric force, kinematic, physiological, and psychometric fatigue, return to activity, motor control, and number of recurrences will be assessed; as well as the quality of life measured through the Western Ontario Shoulder Instability Index, which will be the main outcome variable. A multivariate analysis will be performed through a statistical program to better determine the factors that could influence the results.DiscussionThis study aims to determine if therapeutic exercise supervised by physiotherapists is capable of reducing multivariable fatigue, reducing the number of recurrences, and improving quality of life; to be able to implement it in the future in public and private clinics since materials are available and physiotherapist have enough skills in the field of therapeutic exercise, so it is expected to be a quality tool in the approach to glenohumeral instability.RegistrationRegistry: ClinicalTrials.gov. Number: NCT05443295. Date: 01/07/2022.

Project description:BackgroundAnkle osteoarthritis (OA) is a serious problem with high associated pain and disability. While education and exercise are recommended for the initial management of OA, this has not been investigated in ankle OA. The primary aim of this study is to establish the feasibility of running a full-scale randomised controlled trial (RCT) investigating a combined education and exercise program compared to a general advice program for people with ankle OA. The secondary aims are to collect preliminary data which will inform sample size calculations, and understand the perspectives of people with ankle OA on their participation in the trial.MethodsThirty individuals aged 35 years or older with symptomatic radiographic ankle OA will be recruited from the community and randomised to receive either a combined education and exercise program or a general advice program, both of which will be delivered by a physiotherapist in a group setting. Primary outcomes of feasibility include responses to study advertisements, number of eligible participants, recruitment rate, adherence with the intervention, fidelity of the intervention, adverse events, drop-out rate, and credibility and expectancy of the intervention. Secondary participant-reported outcomes will include global rating of change, patient acceptable symptom state, severity of ankle pain and stiffness, self-reported function, quality of life, satisfaction with treatment, and use of co-interventions. Follow up will be at 8 weeks and 3 months. Physical measures of 40 m walking speed, timed stairs descent, heel raise endurance and ankle dorsiflexion range of motion will be collected at baseline and 8 weeks. Primary feasibility outcomes will be reported descriptively, and estimates of the variability of secondary participant-reported and physical outcomes will be calculated. Semi-structured interviews will be conducted with participants to understand perspectives about the intervention and participation in the trial, with data analyzed thematically.DiscussionStudy findings will establish the feasibility of running a full-scale RCT to investigate a combined education and exercise program compared to a general advice program for people with ankle OA. This study is a necessary first step to advance the international research agenda of evaluating the efficacy of exercise in the management of ankle OA.Trial registrationACTRN12623000017628. Registered 10 January 2023, https://www.anzctr.org.au/ACTRN12623000017628.aspx .

Project description:BackgroundPost-traumatic wrist osteoarthritis (OA) can eventually lead to pain, muscular weakness, and stiffness of the wrist, which can affect the function of the entire upper limb and reduce the quality of life. Although there is strong evidence that all patients with OA should be offered adequate education and exercises as a first-line treatment, an effective self-management program, including structured education and therapeutic exercises, has not yet been introduced for individuals with wrist OA. This trial aims to evaluate the effectiveness of an exercise therapy program with joint protective strategies to improve neuromuscular control (intervention group) compared to a training program with range of motion exercises (control group).MethodsThis is a single-blinded randomized controlled trial (RCT) with two treatment arms in patients with symptomatic and radiographically confirmed wrist OA. The trial will be conducted at a hand surgery department. The participants will be randomly assigned either to a neuromuscular exercise therapy program or to a training program with range of motion exercises only. Participants in both groups will receive a wrist orthosis and structured education on wrist anatomy, pathophysiology, and joint protective self-management strategies. The programs consist of home exercises that will be performed twice a day for 12 weeks. The Patient-Rated Wrist Evaluation (PRWE) is the primary outcome measure of pain and function. Wrist range of motion (ROM), grip strength, the Numeric Pain Rating scale (NPRS), Disabilities of the Arm, Shoulder, and Hand (DASH), the General Self-Efficacy Scale (GSES), Global Rating of Change (GROC), and conversion to surgery are the secondary measures of outcome. Assessments will be performed at baseline and at 3, 6, and 12 months after baseline by a blinded assessor.DiscussionThe upcoming results from this trial may add new knowledge about the effectiveness of a self-managed exercise therapy program on pain and function for individuals with wrist OA. If the present self-management program proves to be effective, it can redefine current treatment strategies and may be implemented in wrist OA treatment protocols.Trial registrationClinicalTrials.gov, NCT05367817. Retrospectively registered on 27 April 2022. https://clinicaltrials.gov .

Project description:BackgroundPhysical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.Methods / designStep-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.DiscussionSTEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.Trial registrationClinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.

Project description:ObjectiveGlenohumeral (GH) osteoarthritis (OA) is the third most common large joint disease, after hip and knee OA. This study aimed to identify risk factors for GH OA.MethodsWe used data from the Dallas Shoulder cohort, including individuals aged 40-85. Those with confirmed GH OA based on X-ray were cases, and those without were controls. Univariate, least absolute shrinkage and selection operator and multivariate analyses identified risk factors, including age, body mass index (BMI), sex, work-related shoulder problems, shoulder disability, dislocation, previous trauma, surgery, smoking, hypertension, diabetes, depression, heart disease, OA, night pain and overall sleep quality.ResultsA total of 1827 cases and 1556 controls were identified for GH OA. In univariate analysis, significant associations with GH OA were found for increasing age (>40 to ≤50: OR 3.29, 95% CI 2.44 to 4.45; >50 to ≤60: OR 5.90, 95% CI 4.49 to 7.77; >60 to ≤70: OR 12.18, 95% CI 9.22 to 16.08 and >70: OR 16.54, 95% CI 12.47 to 21.94), higher BMI (≤19: OR 1.44, 95% CI 1.01 to 2.04; >25 to ≤30: OR 1.57, 95% CI 1.32 to 1.86; >30 to ≤35: OR 1.85, 95% CI 1.54 to 2.22 and >35: OR 1.77, 95% CI 1.28 to 2.45), prior shoulder injury (OR 1.30; 95% CI 1.12 to 1.50), shoulder surgery history (OR 0.71; 95% CI 0.57 to 0.87), shoulder pain at night (OR 1.35; 95% CI 1.07 to 1.70) and hypertension (OR 0.70; 95% CI 0.60 to 0.81). In multivariate analysis, significant associations remained for age (>40 to ≤50: OR 2.99, 95% CI 2.21 to 4.06; >50 to ≤60: OR 5.48, 95% CI 4.14 to 7.23; >60 to ≤70: OR 11.22, 95% CI 8.44 to 14.88 and >70: OR 16.65, 95% CI 12.45 to 22.17), BMI (≤19: OR 1.49, 95% CI 1.01 to 2.20; >25 to ≤30: OR 1.45, 95% CI 1.20 to 1.77; >30 to ≤35: OR 1.70, 95% CI 1.39 to 2.09 and >35: OR 1.78, 95% CI 1.25 to 2.55) and previous shoulder trauma (OR 0.80; 95% CI 0.68 to 0.94).ConclusionWe identified increasing age and higher BMI as factors associated with GH OA. Due to the large sample size, many risk factors were assessed. Since the shoulder is not a weight-bearing joint, the BMI-GH OA link is likely molecular and systemic, warranting further investigation.Level of evidencePrognostic level III.

Project description:BackgroundClinical practice guidelines recommend exercise as the first line of management for hip osteoarthritis, yet high-quality evidence from Cochrane reviews suggest only slight benefits for pain and physical function; and no benefit on quality of life (low-quality evidence). However, the scope of physical impairments identified in people with hip osteoarthritis may not have been adequately addressed with targeted rehabilitation options in previous randomised controlled trials (RCTs). Potential targeted options include gait retraining to address spatio-temporal impairments in walking; motor control training to address deep gluteal (gluteus minimus) dysfunction; and progressive, high-intensity resistance exercises to address atrophy of the gluteal muscles. The aim of this study is to investigate the effect of a targeted gluteal rehabilitation programme that incorporates gait retraining, motor control and progressive, high-intensity resistance-strength training, to address physical activity levels and self-reported physical function in people with mild to moderate disability from hip osteoarthritis.MethodsNinety people diagnosed with mild to moderately disabling hip osteoarthritis will be recruited and randomised to receive one of two exercise programmes (sham or GHOst programme). Interventions will be 12 weeks in duration, with weekly, supervised physiotherapy sessions, and daily home exercises. Both groups will receive standardised education. Outcomes will be assessed at baseline, 7 weeks, 13 weeks (primary time-point) and 25 weeks. The primary outcome will be self-reported physical function measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes include physical activity measured with a tri-axial accelerometer, physical function tests, self-reported physical activity, isometric hip-muscle strength tests, hip-related patient-reported outcome measures, pain thoughts and depressive symptoms, quality of life, global rating of change, gluteal-muscle activity (electromyography (EMG)) and gluteal-muscle size and adiposity (magnetic resonance imaging (MRI)).DiscussionThis will be the first study to compare a targeted gluteal rehabilitation programme to a sham exercise programme. The targeted GHOst programme includes exercises designed to address gait impairments as well as gluteal-muscle atrophy and dysfunction.Trial registrationAustralian New Zealand Clinical Trials Registry, ID: ACTRN12617000970347 . Registered retrospectively on 5 July 2017. Protocol version 3.0.

Dataset Information

Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial.

Background and purpose

Patients and methods

Trial registration

Publications

Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial.

Similar Datasets

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